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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Harvard Business School
Citi
Julphar
Johnson and Johnson
Moodys
Deloitte
Mallinckrodt
Farmers Insurance

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021880

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NDA 021880 describes REVLIMID, which is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are twenty-three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the REVLIMID profile page.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 021880
Tradename:REVLIMID
Applicant:Celgene
Ingredient:lenalidomide
Patents:23
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021880
Suppliers and Packaging for NDA: 021880
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 N 59572-402-00
REVLIMID lenalidomide CAPSULE;ORAL 021880 NDA Celgene Corporation 59572-402 N 59572-402-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Dec 27, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 17, 2018
Regulatory Exclusivity Use:EXPANDED INDICATION FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
Regulatory Exclusivity Expiration:Feb 17, 2022
Regulatory Exclusivity Use:FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE TREATMENT)
Regulatory Exclusivity Expiration:Jun 5, 2020
Regulatory Exclusivity Use:TREATMENT OF MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB

Expired US Patents for NDA 021880

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Sign Up ➤ Sign Up
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-002 Dec 27, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Queensland Health
US Army
Cipla
Mallinckrodt
Express Scripts
Covington
Cerilliant
Deloitte

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